FDA accepts Telix’s NDA for prostate cancer imaging agent

MSK’s Andrea Cercek: Oncology faces learning curve as dostarlimab challenges dMMR rectal cancer standard of care

Earlier this week, FDA granted an accelerated approval to dostarlimab-gxly (Jemperli), for adults with previously untreated stage 2 or stage 3 rectal cancer that is mismatch repair deficient or microsatellite instability-high, marking a celebratory moment for the field.

ASTRO updates guideline on shorter-course radiation therapy for localized prostate cancer

An updated clinical guideline from the American Society for Radiation Oncology provides evidence-based recommendations on the use of hypofractionated radiation therapy for patients with localized prostate cancer.

October 30, 2026

Vol.52 No.40

Clinical Roundup

Perioperative apalutamide in high-risk localized or locally advanced prostate cancer substudy supports reduced risk of metastasis and death

An international phase III clinical trial that treated patients with high-risk localized and locally advanced prostate cancer with apalutamide—a next-generation neoadjuvant androgen-receptor pathway inhibitor—plus hormone therapy before and after prostate cancer surgery, was further validated by a substudy demonstrating a reduced risk of metastasis or death compared with standard of care.

October 30, 2026

Vol.52 No.40

Drugs & Targets

FDA expands approval of Talzenna + Xtandi for an earlier metastatic prostate cancer treatment setting

FDA has expanded approval of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations, including both BRCA and non-BRCA mutations.

October 30, 2026

Vol.52 No.40

Drugs & Targets

FDA releases guidance for sponsors developing gene therapies for rare diseases

FDA is accepting comments on a new regulatory framework that it published for industry sponsors developing personalized gene therapies to treat rare diseases.

FDA authorizes marketing of 24 nicotine pouches

FDA authorized the marketing of 24 nicotine pouch products through the premarket tobacco product application pathway. The authorized products are made by Modoral Brands Inc. under the Velo brand and are all listed as containing 4 mg of nicotine.

October 30, 2026

Vol.52 No.40

FDA accepts Telix’s NDA for prostate cancer imaging agent

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MSK’s Andrea Cercek: Oncology faces learning curve as dostarlimab challenges dMMR rectal cancer standard of care

ASTRO updates guideline on shorter-course radiation therapy for localized prostate cancer

Perioperative apalutamide in high-risk localized or locally advanced prostate cancer substudy supports reduced risk of metastasis and death

FDA expands approval of Talzenna + Xtandi for an earlier metastatic prostate cancer treatment setting

FDA releases guidance for sponsors developing gene therapies for rare diseases

FDA authorizes marketing of 24 nicotine pouches

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